HIV
and AIDS
Human Immunodeficiency Virus and
Acquired Immunodeficiency Syndrome
HIV/AIDS Historical Time Line
1995-1999
1995
- On February 8, FDA approved Mepron (atovaquone) for the treatment
of mild to moderate Pneumocystis carinii pneumonia (PCP) in patients
who are intolerant to trimethoprim-sulfamethoxazole (TMP-SMX).
- On February 23, FDA revised the guidance for Home Specimen Collection
Kit Systems Intended for Human Immunodeficiency Virus (HIV-1 and/or
HIV-2) Antibody Testing.
- On March 24, FDA cleared for marketing the first blood test to
measure latex antibodies in the blood. The test can be used to
help identify people who are allergic to latex and as such assist people
in the use of barrier products to prevent HIV transmission.
- On April 14, FDA approved Chartex International plc. London, U.K.
premarket approval application for the Femidom Female Condom.
The product is an intravaginal barrier device and is indicated for use
to help prevent pregnancy, which will be used as an indicator of the device's
performance in preventing STDs.
- In June 1995, FDA published "An FDA Guide To Choosing Medical
Treatments," FDA Consumer.
- In June 1995, FDA allowed the initiation of an open label study
for saquinavir for the treatment of HIV infection and AIDS. Saquinavir,
manufactured by Hoffmann-La Roche, is the first protease inhibitor made
available outside of ongoing clinical trials.
- On June 6, FDA revised the blood donor criteria to exclude prisoners
from donating blood, blood components and plasma for 12 months from the
last date of incarceration.
- On June 11, FDA issued a Dear Healthcare
Professional letter describing post marketing reports of new
onset diabetes mellitus, hyperglycemia or exacerbation of existing diabetes
mellitus occurring in HIV-infected patients receiving protease inhibitor
therapy, summarizing the reports, and encouraging health care
providers to report such cases, or other serious toxicity associated with
the use of protease inhibitors, to the FDA's MedWatch program.
- On June 16, FDA approved Foscavir (foscarnet) for the treatment
of acyclovir-resistant herpes simplex virus.
- August 1995, FDA recommended that blood establishments should implement
donor screening for HIV-1 antigen using licensed test kits. Although,
currently there are no tests for HIV-1 antigen(s) approved for donor screening,
FDA issued the recommendation on HIV-1 in advance of the availability of
such test in order to provide blood and plasma establishments with maximum
time to prepare for this testing.
- On September 1, FDA authorized pre-approval distribution of intravenous
cidofovir (Vistide) under a treatment IND protocol for HIV-infected
persons relapsing cytomegalovirus (CMV) retinitis that has progressed despite
treatment.
- On September 8, FDA published in the Federal Register a proposed rule to
amend its regulations pertaining to investigational new drug applications
(INDs) and new drug applications (NDAs). The proposed rule is responsive
to one of the recommendations made by the National Task Force on AIDS Drug
Development. The proposed rule would clearly define in the NDA format
and content requirements the need to present effectiveness and safety data
for important demographic subgroups, specifically gender, age, and racial
subgroups.
- On October 12, FDA approved Biaxin (clarithromycin) for the prevention
of Mycobacterium avium complex (MAC).
- On October 27, FDA granted marketing approval for Cytovene capsules
(oral ganciclovir) as a prophylactic treatment for the prevention of HIV-related
cytomegalovirus (CMV) disease.
- On November 17, FDA approved Doxil (doxorubicin HCL liposome injection)
for the treatment of Kaposi's Sarcoma.
- On November 20, FDA granted accelerated approval for Epivir (lamivudine,
3TC) for use in combination with Retrovir (zidovudine, AZT) in
treating AIDS and HIV infection.
- On November 20, FDA approved Abelcet (amphotericin B lipid complex)
for the treatment of aspergillosis.
- On December 6, FDA approved Invirase (saquinavir) the first protease
inhibitor, for use in combination with other nucleoside analogue
medications. This application received approval only 97 days after FDA
received the application for marketing.
- On December 12, FDA released a report, "Timely Access to New
Drugs in the 1990s"An International Comparison," which
documents FDA's tough standards do not delay consumer access to important
new drugs, compared to other countries and that the United States has available
valuable drugs as soon as, and in many cases sooner than, its counterparts
around the world. The average U.S. approval time for antiretroviral agents
was approximately six months.
- On December 21, FDA granted traditional approval for Zerit (stavudine,
d4T) for the treatment of HIV infected adults who have received
prolonged prior AZT therapy. Zerit had previously been approved under the
accelerated approval regulations.
1996
- On March 1, FDA granted full approval for Norvir (ritonavir) for
use alone or in combination with nucleoside analogue medications in people
with advanced HIV disease. Norvir also received accelerated approval for
less advanced HIV disease.
- On March 4, FDA granted full approval for Vitrasert (intravitreal
implant with Cytovene (ganciclovir) for the treatment of CMV Retinitis.
- On March 13, FDA granted accelerated approval for Crixivan (indinavir) for
use alone or in combination with nucleoside analogue medications in people
with HIV or AIDS. FDA approved the drug in just 42 days after receiving its
application for marketing.
- On March 14, FDA approved the first antigen test kit, Coulter HIV-1
p24 Antigen Assay, to screen blood donors for HIV-1. It has been
estimated that HIV-1 antigen screening could prevent approximately 5-10
cases per year or up to 25 percent of current cases of HIV infection transmitted
by transfusion.
- On April 8, FDA granted full approval for DaunoXome (daunorubicin
citrate lipsome injection) for first line cytotoxic treatment of advanced,
HIV-associated Kaposi's Sarcoma
- On May 14, FDA approved the first HIV test system that can be used
at home and can be purchased over-the-counter (OTC). The Confide
HIV Testing System, developed by Direct Access Diagnostics, is
comprised of three integrated components: an OTC home blood collection
kit, HIV-antibody testing at a certified lab, and a test result center
that provides test results, counseling and referral anonymously.
- On June 3, FDA approved Amplicor HIV-1 Monitor Test, an in vitro
nucleic acid amplification test for the quantitation of HIV-1 RNA in human
plasma (viral load). The test is intended for use in conjunction
with clinical presentation and other laboratory markers as an indicator
of disease prognosis.
- On June 3, FDA approved the HIV-1 western blot confirmatory test
for OraSure's oral collection system. The oral collection system
was originally approved in 1994 using an enzyme-linked immunosorbent assay
(ELISA)method.
- On June 12, FDA approved Zithromax (azithromycin) for preventing
or delaying the onset of infection with mycobacterium avium complex (MAC).
- On June 21, FDA granted accelerated approval for Viramune (nevirapine) for
use in combination with nucleoside analogues to treat adults with HIV infection
who have experienced clinical and/or immunological deterioration.
- On June, 26, FDA approved Vistide
(cidofovir) as an intravenous treatment for AIDS-related
CMV retinitis, a potentially severe eye infection that can lead to
blindness.
- On July 17, FDA issued a letter to health care providers regarding
approximately 15 case reports of spontaneous bleeding episodes in HIV positive
patients with hemophilia who were being treated with HIV protease
inhibitors at the time of the event.
- On August 6, FDA approved the first HIV test which uses urine samples.
The urine-based test detects the presence of antibodies to HIV-1 using an
enzyme-linked immunosorbent assay (ELISA) method.
- On August 23, FDA approved Serostim (somatropin rDNA origin for
injection) for treatment of AIDS wasting and cachexia.
1997
- On February 21, FDA approved a supplemental indication for Sporanox
(itraconazole) for the treatment of oropharyngeal and esoplogeal candidiasis.
- On March 14, FDA granted accelerated approval for Viracept (nelfinavir)
the first protease inhibitor labeled for use in children, as well
as adults.
- On March 14, FDA approved pediatric labeling for the protease inhibitor
Norvir (ritonavir).
- On April 4, FDA granted accelerated approval for Resciptor (delavirdine),
a non-nucleoside reverse transcriptase inhibitor (NNRTI), for
use in combination with other antiretroviral drugs for the treatment of
HIV-1.
- On June 11, FDA issued a Public Health Advisory regarding reports
of diabetes and hyperglycemia in patients receiving protease inhibitors
for the treatment of HIV-1.
- On August 4, FDA approved Taxol (paclitaxel) for second line treatment
of AIDS-related Karposi's Sarcoma.
- On September 17, FDA approved Famvir (famciclovir) for the suppression
of recurrent episodes of genital herpes in immunocompetent adults.
- On September 26, FDA approved Combivir, a combined form of AZT
and 3TC, two previously approved antiretroviral drugs for the
treatment of HIV-1.
- On September 26, FDA warned consumers and pharmacists about two
unapproved, fraudulently marketed home-use test kits which were advertised
on the Internet for home HIV and Hepatitis A testing.
- On September 26, FDA issued a final rule requiring labeling of
latex condoms to contain an expiration date based upon physical
and mechanical testing performed after exposing the product to varying
conditions that age latex.
- On November 7, FDA approved Fortovase, a new formulation of Invirase
(saquinavir) for the treatment of HIV-1.
1998
- On January 8, 1998, FDA approved Glyde
Dam Lollyes (Glyde USA, Inc., Redmond, WA 98052-4712) designed
as a barrier for use while performing cunnilingus. When properly
used, it may help reduce the risk of catching or spreading many Sexually
Transmitted Diseases (STDs) such as syphilis, gonorrhea, chlamydia infections,
gential herpes and HIV; however, it cannot completely eliminate the risk.
- On February 27, FDA cosponsored a 2 hour satellite broadcast from
its television studio discussing the Guidelines for the Use of Antiretroviral
Agents in HIV-Infected Adults and Adolescents.
- On May 6, 1998, FDA approved a virally inactivated, processed blood
product (SD Plasma) manufactured from
pooled human plasma that can serve as an alternative to fresh frozen plasma.
The manufacturing process for this new product includes a solvent detergent
procedure that inactivates some blood-borne viruses such as HIV.
- On May 28, 1998, FDA approved Cambridge
Biotech HIV-1, a Human Immunodeficiency virus Type 1 (Western Blot)
test with a new indication for urine specimen testing.
- On June 12, 1998, FDA approved Famvir (famciclovir/SmithKline Beechman)
for the additional indication for the treatment of recurrent mucocutaneous
herpes simplex infections in HIV-infected patients at a dose of
500 mg twice daily.
- On July 22, 1998 FDA cosponsored a 2 hour satellite broadcast from
its television studios discussing the Guidelines for the Use of Antiretroviral
Agents in Pediatric HIV Infection.
- On July 23, 1998, FDA issues guidance to manufacturers of Latex
Condoms for Men - Information for 510(k) Premarket Notifications:
Use of Consensus Standards for Abbreviated Submissions ( pdf
file)
- On August 26, 1998, FDA approved Vitravene Injection (fomivirsen
sodium intravitreal injectable), Isis Pharmaceuticals, for the local treatment
of cytomegalovirus (CMV) retinitis in patient with acquired immunodeficiency
syndrome (AIDS) who are intolerant of or have a contraindication to other
treatment(s) for CMV retinitis or who were insufficiently responsive to
previous treatment(s) for CMV retinitis.
Approval Letter and Labeling.
- On September 17, 1998, FDA approved Sustiva (efavirenz), DuPont Pharmaceuticals,
to treat HIV and AIDS.
Approval Letter
Approved Labeling
Sustiva Consumer Information
- On December 17, 1998, FDA granted accelerated approval for Ziagen (abacavir),
Glaxo Wellcome, to treat HIV-1 in adults and children.
1999
- Mepron (atovaquone, Glaxo Wellcome) Suspension was approved on
January 5, 1999 for the prevention of Pneumocystis carinii pneumonia
(PCP).
- Panretin (alitretinoin) gel 0.1% was approved on February
2, 1999 for the topical treatment of cutaneous lesions in
patients with AIDS-related Kaposi's sarcoma. The manufacturer
is Ligand Pharmaceuticals.
Approval Letter | Approved Labeling
- On February 17, 1999, a Businessman was Sentenced
to Over Five Years for Selling Bogus HIV-Testing Kits
- February, 1999 - Glass Capillary Tubes: Joint
Safety Advisory About Potential Risks, . This document discusses the potential
risk of injury and/or infection from bloodborne pathogens, including HIV,
hepatitis B and hepatitis C viruses, due to the accidental breakage of glass
capillary tubes, and to recommend certain steps that can minimize the risk.
- On March 2, 1999, FDA approved a supplement to AMPLICOR
HIV-1 MONITOR Test (Roche Molecular Systems, Inc.). This supplemental
approval extends the lower limit of quantitation from 400 HIV RNA copies/mL
down to 50 copies/mL; the upper limit of quantitation, 750,000 HIV RNA
copies/mL remains the same. It is intended for use in conjunction with
clinical presentation and other laboratory markers of disease progress
for the clinical management of HIV-1 infected patients. On the same
date, another supplement was
approved for patient monitoring and it can
be used as an aid in management of patients on anti-viral therapy for HIV
disease. The original application, approved June 3, 1996, was for disease
prognosis in conjunction with clinical presentation and other laboratory
markers.
(Labeling, 53 pages in PDF)
- On March 29, 1999, Kenneth Thiefault and his wife Mardol Barber were sentenced
in a Florida court for their conviction last year on conspiracy, distribution
of an Ozone Generator, mail fraud, wire fraud, and tax violations.
The court sentenced Mr. Thiefault to 72 months of incarceration (to be followed
by 3 years of supervised release), imposed a $100,000 fine, and ordered payment
of $14,400 in restitution. The court sentenced the Ms. Barber to 33
months of incarceration (to be followed by 3 years of supervised release)
and imposed a fine of $60,000. Additionally, the court ordered both
defendants to help the IRS compute their back taxes and banned both defendants
from participating in any securities or telemarketing businesses in the future.
The couple were making claims that the ozone generators can oxidize toxins
in the body and cure everything from gangrene to cancer to AIDS.
- On April 15, 1999, FDA granted accelerated approval to Agenerase (amprenavir,
Glaxo Wellcome, Inc.) 50 mg, 150 mg capsules and oral solution. Agenerase
is a protease inhibitor that is indicated, in combination with other antiretroviral
agents, for the treatment of HIV-1 infection. This indication is based
on analyses of plasma HIV RNA levels and CD4 cell counts in controlled studies
of up to 24 weeks in duration. At present, there are no results from controlled
trials evaluating long-term suppression of HIV RNA or disease progression
with Agenerase.
- On June 29, 1999, FDA granted marketing approval for Norvir (ritonavir,
Abbott Laboratories) 100 mg soft gelatin capsules.
- On August 17, 1999, FDA issued afinal rule on OTC
Drug Products Containing Colloidal Silver declaring that
all OTC drug products containing colloidal silver or silver salts are
not recognized as safe and effective and are misbranded. Colloidal
silver is a suspension of silver particles in a colloidal (gelatinous)
base. In recent years, colloidal silver preparations of unknown
formulation have been appearing in stores for the treatment of HIV/AIDS
and other life threatening diseases.
- On December 10, 1999, FDA took Action
Against a Firm Marketing Unapproved Drugs , MGN-3, a rice
bran extract, as a treatment for cancer and HIV.
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