| Study
Number |
Title
and Desciption |
ACTG
371
NAIVE
TREATMENT
|
(those who have
not tested HIV-positive but suspect they may have had an exposure
may come in to be tested)
A
Trial to Evaluate the Safety and Efficacy of Induction
Treatment with Lamivudine plus Stavudine plus Abacavir plus
Amprenavir/Ritonavir Followed by Supervised
Treatment Interruption in Subjects with Acute
HIV Infection or Recent Seroconversion
Patient
Population:
Subjects with acute HIV infection or recent seroconversion
Study Objective:
To assess if potent antiretroviral intervention early in the course
of HIV infection, followed by supervised treatment interruption,
can lead to sustained controlled viral load levels (<5000) off
study therapy
|
ACTG
723
PROSPECTIVE
|
Effect
of Antiretroviral Therapy on Viral Burden
and Immune Function in the Lungs of HIV-Infected
Subjects
Patient Population:
HIV-positive subjects scheduled to begin potent antiretroviral treatment.
Subjects must have no prior exposure to protease inhibitors or non-nucleoside
reverse transcriptase inhibitors.
Study Objective:
To evaluate if HIV viral load in bronchoalveolar lavage cells and
fluid correlates with viremia |
ACTG
736
OBSERVATIONAL
|
Cerebrospinal
Fluid Human Immunodeficiency
Virus and Cognitive Function in Individuals
Receiving Potent Antiretroviral Therapy
Patient Population:
Subjects enrolled in AACTG-sponsored potent antiretroviral therapy
trials
Study Objective:
To compare the magnitude of durability of suppression of viral load
in plasma and CSF compartments in response to potent antiretroviral
therapy |
ACTG
A5029
NAIVE
PROSPECTIVE
OBSERVATIONAL
|
Assessment
of Prevalence and Persistence of Human Papilloma
Virus (HPV) DNA in HIV-Infected Women Who are Antiretroviral
Naive and have Initiated HAART
Patient Population:
HIV infected, antiretroviral-naïve women
Study Objectives:
1) To estimate the prevalence of HPV DNA detection at baseline
2) To estimate the rate of conversion from positive at baseline to
negative HPV DNA at week 48 for women responding to HAART at week
48 |
ACTG
A5030
PROSPECTIVE
TREATMENT |
A
Phase III, Prospective, Randomized, Double-Blind Trial of Valganciclovir
Pre-Emptive Therapy for Cytomegalovirus (CMV)
Viremia as Detected by Plasma CMV DNA PCR Assay
Patient Population:
HIV-infected, CMV-seropositive persons who currently are receiving
no CMV prophylaxis and have no evidence of CMV end-organ disease.
Subjects must be already chronically receiving potent antiretroviral
therapy or not be receiving potent antiretroviral therapy and be unlikely
to receive it in the future.
Study Objectives:
To evaluate pre-emptive oral valganciclovir in preventing CMV end-organ
disease in CMV DNA PCR positive subjects
|
ACTG
A5068
TREATMENT
|
A
Randomized Phase I/II Study of Intermittent
Withdrawal of
Antiretroviral Therapy as an Immunization Strategy and Double-Blinded
Immunization with ALVAC-HIV vCP1452 in
Subjects with Persistent CD4+
Cell Counts Greater than 500 cells/mm3 & Undetectable Pl
Patient Population:
Subjects currently receiving their first potent antiretroviral treatment
(potent ART). Subjects known to have HIV-1 seroconverted within a
year before study entry will not be eligible to participate in the
study.
Study Objectives:
1) To compare the effect of different methods of antigen stimulation
(intermittent potent ART withdrawal versus ALVAC versus both) versus
no antigen stimulation
2)
To establish the safety of intermittent withdrawal of antiretroviral
therapy with and without HIV-specific vaccine in subjects |
ACTG
A5073
NAIVE
TREATMENT
|
A
Randomized Phase II Open Label Study to Compare Twice
Daily Potent Antiretroviral Therapy With Once
Daily Potent Antiretroviral Therapy and to Compare Self-Administered
Therapy and Therapy Administererd Under Direct
Observation
Patient Population:
HIV-infected subjects who are antiretroviral
naive, and who have plasma HIV RNA levels >2000 copies
Study Objectives:
To compare the
ability of a potent antiretroviral regimen to achieve a sustained
virologic response in HIV-1 infected subjects through week 48 when
given twice daily and when given once daily
To compare the ability of a potent antiretroviral regimen to achieve
a sustained virologic response in HIV-1 infected subjects through
week 24 when self-administered and when administered under direct
observation |
ACTG
A5079
PROSPECTIVE
TREATMENT
|
Prospective,
Multicenter, Randomized, Placebo-controlled trial of Physiologic Testosterone
Supplementation for Men with Mild to Moderately Reduced Serum
Testosterone Levels and Abdominal Obesity
Patient Population:
HIV-positive men with abdominal obesity and mild to moderately reduced
serum
testosterone levels who have been on a stable potent antiretroviral
regimen for at least three months
Study Objective:
To test the hypothesis that the change in the visceral fat cross-sectional
area will be greater with testosterone replacement than with placebo |
ACTG
A5082
PROSPECTIVE
TREATMENT
|
A
Randomized, Double-Blind, Placebo-Controlled Study of Metformin
and Rosiglitazone, Alone or in Combination,
in HIV-infected Subjects with Fasting Hyperinsulinemia
and Elevated Waist/Hip Ratio
Patient Population:
Men and women
who are HIV-infected, viral load < 10,000 copies, have fasting
hyperinsulinemia, and have developed fat redistribution during the
course of their HIV disease
Study Objective:
To determine the
effects of metformin and rosiglitazone on fasting insulin levels |
ACTG
A5084
PROSPECTIVE
OBSERVATIONAL
|
Evaluation
of Metabolic Complications Associated
With Antiretroviral Medications in HIV-1 Infected Pregnant
Women
Patient
Population:
HIV-infected pregnant women aged > 13 years and between
20 and 34 weeks gestation and their infants
Study
Objectives:
To determine whether PI therapy increases the relative risk for impaired
glucose tolerance (IGT) among HIV-infected pregnant women |
ACTG
A5092S
OBSERVATIONAL
|
Pharmacokinetics
Evaluation of the Effects of Ribavirin on Zidovudine (ZDV) or Stavudine
(d4T) Triphosphate Formation
Patient
Population:
HIV-infected
subjects who also have Hepatitis C. Subjects are eligible if
they are receiving ZDV or d4T and ready to initiate ribavirin treatment
for their Hepatitis C
Study
Objectives:
To
evaluate any alterations ribavarin may have on ZDV or d4T |
ACTG
A5110
PROSPECTIVE
OBSERVATIONAL
|
A
Restrictively Randomized, Open-Label, Controlled, Pilot
Study of the Effect of a Thymidine Analogue
Substitution or Change to a Nucleoside-Sparing Regimen on Peripheral
Fat Wasting
Patient
Population:
HIV-infected subjects with CD4 >100 who present with
peripheral fat wasting
Study
Objectives:
To investigate
the effect of treatment changes on subcutaneous and visceral fat tissue
distribution in the abdomen, and changes in adipose and lean tissue.
|
ACTG
A5115
TREATMENT
PROSPECTIVE
|
A
Phase II Randomized, Controlled, Pilot Study of Antiretroviral
Switch at Lower versus Higher HIV-1 RNA Levels in Subjects
Experiencing Virologic Relapse on a Current
HAART Regimen
Patient
Population:
HIV-infected subjects who has experienced
virologic relapse on their current stable HAART regimen with three
most recent viral loads prior to pre-entry between 200-10,000 copies
and CD4 cell counts 200
Study
Objectives:
To evaluate whether low levels of immune activation are maintained
in subjects in the delayed switch arm as compared to subjects in the
immediate switch arm. Additionally, to compare the evolution of genotypic
drug resistance at week 48 in the two arms using a quantitative measure
of future drug options. |
ACTG
A5126
TREATMENT
PROSPECTIVE
OBSERVATIONAL
|
A
Phase II Study of the Predictive Value of Pharmacokinetic-Adjusted
Phenotypic Susceptibility (C12/IC50) on Antiretroviral Response to
Ritonavir-Enhanced Protease Inhibitors
in Subjects with Failure of
Previous Protease Inhibitor-Based Regimens
Patient
Population:
HIV-infected subjects with HIV-RNA >5000 who have experienced
failure of previous protease inhibitor regimens
Study
Objectives:
To compare antiretroviral responses of ritonavir-enhanced protease
inhibitors (indinavir, kaletra, amprenavir 908); tenofovir will be
added at Day 15 |
ACTG
A5127
TREATMENT
|
A
Randomized, Phase II, Controlled Trial of the Activity of Adefovir
Dipivoxil and Tenofovir Disoproxil
Fumarate for the Treatment of Lamivudine - Resistant
Hepatitis B Virus (HBV) in Subjects who are
Co-infected with HIV
Patient
Population:
HIV
and HBV coinfected subjects
Study
Objectives:
To assess the clinical response of adefovir
versus tenofovir in combination with 3TC in chronic HIV/HBV-coinfected
subjects |
ACTG
A5141
TREATMENT
PROSPECTIVE
OBSERVATIONAL
|
Randomized
Study to Evaluate Immediate Potent Antiretroviral Therapy for HIV-Infected
Subjects with CD4 Cell Counts < 200 Cells/mm3 Admitted to Intensive
Care Areas with an AIDS-Defining Illness,
Pneumonia, or Sepsis
Patient
Population:
This study will look at whether starting Highly Active
Antiretroviral Therapy (HAART) in patients with CD4 counts < 200
who are sick enough to be in an Intensive Care Area will help people
survive and get better faster
Study
Objectives:
To learn whether starting medicines that fight HIV while hospitalized
in the Intensive Care Areas will help people survive and get better
faster |
ACTG
A5143
TREATMENT
|
A
Randomized, Comparative Study of LPV/RTV vs.GW433908
+ RTV vs. LPV/RTV + GW433908 (in Combination with Tenofovir
Disoproxil Fumarate and One or Two Nucleoside Reverse Transcriptase
inhibitors) in HIV-1-Infected Subjects with Virologic Treatment
Failure
Patient
Population:
HIV-infected
individuals, PI experienced, with extensive prior exposure to
antiretroviral therapy. Viral load >5000 copies and naïve
to either: 1) LPV or 2) APV and 908, or 3) LPV and APV and 908.
Study
Objectives:
To compare the antiretroviral activity,
safety and tolerability of LPV/RTV + 908 to the combined 908 + RTV
andLPV/RTV arms. |
ACTG
A5146
PROSPECTIVE
OBSERVATIONAL
|
A
Randomized Controlled Trial Evaluating the Impact of Therapeutic
Drug Monitoring on Virologic Response
to Salvage Regimen Selected Using Phenotypic
Resistance testing or VirtualPhenotype
Patient
Population:
HIV-infected subjects who are virologically
failing their second, third, or fourth combination antiretroviral
regimen. At least one of these failing regimens must have contained
a PI. For this protocol, virologic failure on a prior regimen is defined
as HIV RNA of >400 copies. The screening HIV RNA value must be
> 2000.
Study
Objectives:
To compare the mean change in HIV RNA between
the Therapeutic Drug Monitoring + Standard of Care (SOC) and SOC arms |
ACTG
A5165
TREATMENT
|
A
Phase I/II Randomized, Double-Blind, Placebo-Controlled Pilot Study
of b-D-2,6-Diaminopurine Dioxolane (DAPD)
vs. DAPD plus MMF (Mycophenolate mofetil)
Treatment Experienced Patients
Patient
Population:
Antiretroviral-experienced
HIV-infected men and women who have virologic failure on their current
antiretroviral regimen
Study
Objectives:
To compare the short-term safety, tolerability,
and antiretroviral activity of DAPD and MMF in antiretroviral-experienced
subjects |
